Autotitrating method and apparatus

ABSTRACT

An apparatus and method of controlling the delivery of therapeutic gas delivered to a patient undergoing positive airway pressure therapy is described. The method includes providing a flow of gas to a patient&#39;s airway at a pressure, obtaining information from the range of 0 to 25 Hz of the frequency domain of the flow, and adjusting the pressure based on the information. The apparatus includes a blower for providing a flow of gas to a patient&#39;s airway at a pressure, a sensor to measure a characteristic of the flow, a controller to obtain information from the range of 0 to 25 Hz of the frequency domain of the characteristic, and a pressure regulator for adjusting the pressure based on the information.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/198,072, filed Aug. 5, 2005, which claims the benefit of U.S.provisional patent application Ser. No. 60/599,356, filed on Aug. 6,2004. The disclosure of both prior applications is incorporated hereinby reference in its entirety.

FIELD OF THE INVENTION

This invention is generally directed to a method and apparatus forcontrolling the positive air pressure applied to a patient undergoingpositive airway pressure therapy.

BACKGROUND OF THE INVENTION

Obstructions in some patients' airways during sleep can cause limitedairflow, leading to apnea, hypopnea, or snoring. The obstruction isoften a collapsed pharynx. The obstruction may be a partial airwayobstruction, leading to altered characteristics of the airflow. Ahyperpnoea is a reduction of flow that is greater than fifty percent,but not complete. An apnea, however, is a complete cessation of airflow.Each of these conditions frequently leads to sleep deprivation.

It is well known to treat patients suffering from sleep deprivation withpositive airway pressure therapy (“PAP”). This therapy can be ContinuousPositive Airway Pressure (“CPAP”), Variable Positive Airway Pressure(“VPAP”), Bi-level Positive Airway Pressure (“BiPAP”), or any ofnumerous other forms of respiratory therapy. The application of positivepressure to the patient's pharynx helps minimize or prevent thiscollapse. Positive airway pressure therapy is currently applied by meansof an apparatus containing a pressure source, typically a blower,through a tube to a mask, which the patient wears in bed.

It is desired to control the applied pressure. Too little pressure tendsnot to solve the problem. Too much pressure tends to cause discomfort tothe patient, such as drying out of the mouth and pharynx, as well asdifficulty in exhaling against the applied pressure. The difficulty inapplying optimum pressure is that incidents of airway obstruction comeand go through the course of a night's sleep. One solution is to try tofind an optimum pressure for a particular patient and maintain thatpressure. This method requires the patient's stay at a sleep clinic,where sleep specialists can monitor the patient's course of breathingthroughout one or more night's sleep, prescribe the appropriate pressurefor that patient, and then set the apparatus to deliver the appropriatepressure. This method is, of course, inconvenient as well as expensiveto the patient and tends to be inaccurate, as a typical patient will notsleep the same when away from familiar bedding and surroundings.

Accordingly, it is desirable to be able to adjust the applied pressurewithout requiring the patient to attend at a sleep center. Variousmethods of in-home adjustments have been considered. One methodgenerally thought to be effective is to monitor the patient to try toanticipate the onset of an obstructed airway, and to adjust the pressurein response. When an elevated upper airway resistance or flowobstruction is anticipated or underway, the apparatus increases theapplied pressure. When the patient returns to normal sleep, the appliedpressure is reduced. The problem then, is to determine when a flowobstruction is occurring or is about to occur. It is desired toanticipate correctly in order to avoid the problems set forth above forwhen too much or too little pressure is applied.

Various methods have been proposed to solve this problem. In U.S. Pat.No. 5,107,831 to Halpern, an apparatus monitors the airflow to thepatient and posits an event of airway obstruction when the patient'sbreath fails to meet a predetermined threshold of flow rate or duration.In U.S. Pat. No. 5,1345,995 to Gruenke, an apparatus monitors theairflow to the patient and analyzes the shape of the flow versus timewaveform. If the shape of this waveform tends to be flattened, that is,more similar to a plateau than to a sinusoid, the apparatus posits anevent of airway obstruction. In U.S. Pat. No. 5,245,995 to Sullivan, anapparatus monitors the patient's sound with a microphone. If audiblesnores are detected, the apparatus posits an event of airwayobstruction. Similarly, in U.S. Pat. No. 5,953,713 to Behbehani, anapparatus measures the total pressure within an interface placed over apatient's airway and inputs frequency data in the range 100 to 150 Hzinto a neural network to determine the presence of a pharyngeal wallvibration (a snore) which, according to Behbehani, is a precursor tosleep disorder breathing.

These methods have not proven totally satisfactory in controlling theapplied pressure during PAP therapy. For example, the '713 patent, bymeasuring in the range of 100 to 150 Hz, essentially tests for snoringand does not measure or analyze any information concerning partialairway obstruction (as described within the present application), asthis information is found in the lower frequency range 0 to 25 Hz. FIGS.1 and 2 are plots in the frequency domain of energy v. frequency oftypical breathing. As can be seen, there is a marked difference betweennormal breathing and breathing characterized by a partial airwayobstruction, all in low frequencies. The present application exploitsthis difference to control the delivery of therapeutic gas.

Moreover, the methods of the prior art are unsatisfactory in analyzing asignal in a high-noise environment. The inventors herein have discoveredan alternate way to detect the onset of an event of airway obstructionand to control the applied pressure from a high-noise signal such asresults from a person's breathing over the course of a night.Accordingly, the method and apparatus of the present invention fulfillthe need for analyzing a signal from a patient in order to control theapplied pressure during PAP therapy.

SUMMARY OF THE INVENTION

The present invention in one embodiment is a method of controllingpositive airway pressure therapy by providing a flow of gas to apatient's airway at a pressure, obtaining information from the frequencyrange of zero to 25 HZ in the frequency domain of the flow, andadjusting the pressure based on the information. In another embodiment,the present invention is an apparatus for providing controlled positiveairway pressure therapy, having a blower for providing a flow of gas toa patient's airway, a sensor to measure a characteristic of the flow, acontroller to obtain information from the frequency range of zero to 25HZ in the frequency domain of the characteristic, and a pressureregulator for adjusting the pressure based on the information.

BRIEF DESCRIPTION OF THE DRAWINGS

The organization and manner of the structure and operation of theinvention, together with further objects and advantages thereof, maybest be understood by reference to the following description, taken inconnection with the accompanying drawings, wherein like referencenumerals identify like elements in which:

FIG. 1 is a plot in the frequency domain of energy v. frequency fornormal breathing and breathing characterized by partial airwayobstruction;

FIG. 2 is also a plot in the frequency domain of energy v. frequency fornormal breathing and breathing characterized by partial airwayobstruction;

FIG. 3 is a diagram of an exemplary positive airway pressure apparatusof the preferred embodiment of the present invention;

FIG. 4 is a block diagram of the main algorithm of the method of thepreferred embodiment of the present invention, showing the interactionof the five algorithms;

FIG. 5 is a block diagram of the Breath Detection Algorithm of thepreferred embodiment of the present invention;

FIG. 6 is a block diagram of the Partial Airway Obstruction Algorithm ofthe preferred embodiment of the present invention;

FIG. 7 is a block diagram of the Apnea Detection Algorithm of thepreferred embodiment of the present invention;

FIG. 8 is a block diagram of the Hypopnea Detection Algorithm of thepreferred embodiment of the present invention;

FIGS. 9 a, 9 b, 9 c, and 9 d are block diagrams of the PressureAdjusting Algorithm of the preferred embodiment of the presentinvention;

FIG. 10 is a diagram of airflow versus time, illustrating T_(start) andM_(f); and

FIG. 11 is a diagram of airflow versus time, illustrating T_(end), t₁,t₂ and M_(t1-t2).

DETAILED DESCRIPTION OF THE INVENTION

While the invention may be susceptible to embodiment in different forms,there is shown in the drawings, and herein will be described in detail,a specific embodiment with the understanding that the present disclosureis to be considered an exemplification of the principles of theinvention, and is not intended to limit the invention to that asillustrated and described herein.

A positive airway pressure apparatus 100 of the preferred embodiment ofthe present invention is shown in FIG. 3 in which the patient 1 receiveshumidified, pressurized gas through an inspiratory conduit 3. It shouldbe understood that the delivery systems could be CPAP (ContinuousPositive Airway Pressure), VPAP (Variable Positive Airway Pressure),BiPAP (Bi-level Positive Airway Pressure), or any of numerous otherforms of respiratory therapy. The apparatus 100 and method 200 of thepresent invention will be described as used for CPAP but an artisan ofordinary skill in the art will readily adapt both for use with VPAP,BiPAP, or another positive airway pressure therapeutic system.

Inspiratory conduit 3 is attached at one end to a mask 2, preferably onesuch as is described in U.S. Pat. No. 6,662,803. Inspiratory conduit 3connects at its other end to the outlet 4 of a humidification chamber 5,which contains a volume of water 6. Inspiratory conduit 3 may containheating heater wires (not shown) or other suitable heating elements thatheat the walls of the conduit to reduce condensation of humidified gaseswithin the conduit. Humidification chamber 6 is preferably formed from aplastic material and may have a highly heat-conductive base (for examplean aluminum base) that is in direct contact with a heater plate 7 ofhumidifier 8.

Electronic controller 9 controls the various components of the apparatus100. Controller 9 may be a microprocessor-based controller containing,as is well known in the art, RAM, ROM, an ALU, one or more registers, adata bus, counters (including at least a breath number counter 120 and apressure decrease counter 130), and one or more buffers (including atleast a circular buffer 110). Controller 9 executes computer softwarecommands stored in its RAM and ROM.

Controller 9 receives input from sources such as user input dial 10through which a user of the device may, for example, set a predeterminedrequired value (preset value) of various characteristics of the gasessupplied to the patient 1, such as initial airflow, pressure, humidity,or temperature of the gases. Controller 9 preferably receives inputrelating to airflow from differential pressure sensor 11, which ispreferably located in blower 15. Differential pressure sensor 11 couldalternatively be located elsewhere, upstream of mask 2, such as withinconduit 3 or anywhere on mask 2. Alternatively, controller 9 may receiveinput related to airflow by direct measurement of flow at any point fromblower 15 to mask 2. Controller 9 may also receive input from othersources, for example temperature sensors 12 through connector 13 andheater-plate temperature sensor 14.

In response to the user-set inputs and the other inputs, controller 9determines when (or to what level) to energize heater plate 7 to heatthe water 6 within humidification chamber 5. As the volume of water 6within humidification chamber 5 is heated, water vapor begins to fillthe volume of the chamber 5 above the water's surface and is passed outof the outlet 4 of humidification chamber 5 with the flow of gases (forexample air) provided from a gas supply device such as blower 15, whichgases enter the chamber 5 through inlet 16. Exhaled gases from thepatient 1 are passed directly to ambient surroundings in FIG. 3.

Blower 15 is provided with a variable-pressure regulating device such asvariable speed fan 21, which draws air or other gases through blowerinlet 17. The speed of variable speed fan 21 is controlled by electroniccontroller 9 in response to inputs from the various components ofapparatus 100 and by a user-set predetermined required value (presetvalue) of pressure or fan speed via dial 19.

Controller 9 is programmed with five algorithms:

-   -   1. Breath Detection Algorithm;    -   2. Apnea Detection Algorithm;    -   3. Hypopnea Detection Algorithm;    -   4. Partial Airway Obstruction Detection Algorithm; and    -   5. Pressure Adjusting Algorithm.

These algorithms interact as diagramed in FIG. 4. When the patient 1turns on the apparatus 100, the controller 9 receives data from pressuresensor 11 and starts the main algorithm (step 200). Pressure sensor 11is preferably a differential pressure sensor, and controller 9 convertsdifferential pressure data to airflow data. Controller 9 samples the rawanalogue flow signal at 50 Hz (step 202) and calculates bias flow (step204). Bias flow, such as occurs from leaks in the mask 2 or elsewhere inthe apparatus 100, is obtained preferably via a Butterworth low-passfilter (with a rise time of approximately thirty seconds). Theinformation stored in circular buffer 110 in controller 9 is thereforenet airflow data, as the controller 9 removes the bias flow (step 206).Circular buffer 110 in controller 9 is continuously updating data andstoring that data for 15 seconds (step 208). Accordingly, throughoutthese algorithms, the flow being analyzed does not contain the biasflow. That is, the flow oscillates about zero flow.

The incoming flow data is continuously checked for the presence of aleak (step 210). If a significant leak is detected the algorithm ispaused until the leak is resolved.

If there are no leaks and fewer than ten breaths have passed, thecurrent data is analyzed by the Breath Detection Algorithm (step 300),as will be described in connection with FIG. 5. The Breath DetectionAlgorithm determines where the oldest breath begins and ends.

If no breath is detected (step 212), the main algorithm starts over withsampling the raw analogue flow signal (step 202). If a breath isdetected (step 212), a breath number counter 120 is incremented (step214), and the main algorithm starts over with sampling the raw signal(step 202).

Since it is assumed that the patient 1 will breathe a minimum of tenbreaths before any apneas or hypopneas occur, the main algorithm of thepreferred embodiment counts to determine if at least ten breaths haveoccurred (step 216). If more than ten breaths have occurred, theapparatus proceeds to the Apnea Detection Algorithm (step 500), as willhereinafter be described in connection with FIG. 7. If fewer than tenbreaths have occurred, circular buffer 110 in controller 9 continues tosample raw analogue data (step 202).

Once ten breaths have occurred, the main algorithm proceeds as diagramedin FIG. 4. The Apnea Detection Algorithm (step 500) constantly checksthe real-time incoming flow to see if an apnea is occurring (step 218),as will be described in greater detail in connection with FIG. 7. If anapnea is occurring, the Pressure Adjusting Algorithm (step 700) iscalled, as will be described in connection with FIG. 9. Once the apneahas finished (step 220), the main algorithm starts over with samplingraw data (step 202). If no apnea is occurring, the Breath DetectionAlgorithm (step 300) is called.

If no new breath has been detected (step 222), the algorithm checks tosee if 2.5 minutes have passed since the last partial obstruction orapnea (step 224). If not, the main algorithm starts over with samplingraw data (step 202). If so, the Pressure Adjusting Algorithm (step 700)is called. If a breath is detected, the Hypopnea Detection Algorithm iscalled (step 600), as will be described in connection with FIG. 8,followed by the Partial Airway Obstruction Algorithm (step 400) as willbe explained in connection with FIG. 6.

The Hypopnea Detection Algorithm (step 600) checks to see if a breath ispossibly part of a hypopnea. The Partial Airway Obstruction Algorithm(step 400) is called to check for partial airway obstruction (step 232).If the Hypopnea Detection Algorithm finds that a hypopnea has occurred(step 226), the main algorithm checks to see if any breaths in thehypopnea showed partial airway obstruction (step 228). If so, thePressure Adjusting Algorithm is called (step 700). If not, the mainalgorithm checks to see if 2.5 minutes have passed since the lastpartial obstruction or apnea event (step 230). If so, the PressureAdjusting Algorithm is called (step 700). If not, the main algorithmstarts over with sampling raw data (step 202).

The Partial Airway Obstruction Algorithm checks for partial airwayobstruction (step 232) in the event a hypopnea has not occurred. If thecurrent breath shows a partial airway obstruction, the main algorithmchecks to see if the previous two breaths have shown a partial airwayobstruction (step 234). If so, the Pressure Adjusting Algorithm (step700) is called. If the current breath does not show a partial airwayobstruction (step 232) or if the previous two breaths do not show apartial airway obstruction (step 234), the main algorithm checks to seeif 2.5 minutes have passed since the last partial obstruction or apneaevent (step 224). If so, the Pressure Adjusting Algorithm (step 700) iscalled; if not, the main algorithm starts over with sampling raw data.

Using the above algorithms, the applied positive airway pressure is atthe lowest pressure required by the patient 1 to achieve therapeutictreatment. The details of the algorithms will now be explained.

Breath Detection Algorithm

Two routines are used, as diagramed in FIG. 5, depending on how manybreaths have been detected since the program was initiated. The tworoutines differ, in that one incorporates the breathing period of thepatient 1.

The Breath Detection Algorithm (step 300) initially determines if aprevious breath's end is still contained within the flow buffer (step302). If a previous breath's end point is still in the flow buffer, thestart of the next breath (beginning of inspiration, or T_(start)) willbe the data point following the end point of the previous breath (step304). If the previous breath's end point is not in the buffer (such asif an apnea occurred), the new end point is determined, once a piece offlow data greater than five liters per minute is immediately followed bya piece of flow data less than 5 liters per minute has occurred (step306), by searching the flow buffer to find E_(f) where E_(f) is 0.15times the maximum flow in the buffer (step 308), and where flow isincreasing, that is, flow is less than E_(f) followed by flow greaterthan E_(f) (step 310). The new end point T_(end) is then set as thestart of the next breath (step 304).

At this point, the algorithm determines whether more than twenty breathshave occurred (step 312). If so, the algorithm searches to find M_(f),the maximum flow over the last one-quarter of the average breathingperiod after T_(start) (step 314). If twenty or fewer breaths haveoccurred, M_(f) is defined as the maximum flow in the next second afterT_(start) (step 316).

The end point of expiration, T_(end), is determined by searching betweentwo reference points (step 318) (reference points t₁, t₂ are shown inFIG. 10, a plot of airflow to the patient, as determined fromdifferential pressure sensor 11, versus time). Each reference point t₁,t₂ is identified by determining the occurrence of a flow data valuegreater than the reference value followed by a flow data value less thanthe reference value (steps 320, 322), where t₂ is after t₁, which isafter T_(start).

The reference value is given by:

reference value=0.2×M _(f)

where M_(f) is the maximum flow in 0.25×average breathing period sincethe beginning of inspiration (as found in step 314).

M_(f) is illustrated in FIG. 10, also a plot of airflow to the patient1, as determined from differential pressure sensor 11, versus time.

The period between t₁ and t₂ should be greater than 0.5 sec (step 326).If not, t₂ is found again (step 322). The maximum flow, greater thanzero, between the two reference points t₁, t₂ is calculated and used todetermine the end of expiration E_(f) (step 328). The end of expirationis:

E _(f)=0.15×M _(t1-t2)

where

M_(t1-t2)=maximum flow between t₁ and t₂

M_(t1-t2), t₁, and t₂ are illustrated in FIG. 11.

A flow data value less than E_(f) immediately followed by a flow datavalue greater than E_(f) indicates the end of the breath T_(end) (step330). The breath is therefore from T_(start) to T_(end) (step 332). Theapparatus then stores the maximum flow M_(t1-t2), provided the breath isnot part of a hypopnea, as determined by the Hypopnea DetectionAlgorithm (step 600), as will be hereinafter described, and stores theperiod of the breath (step 334).

The period of the breath and the maximum inspiratory flow are used bythe Apnea Detection Algorithm (step 500) and the Hypopnea DetectionAlgorithm (step 600), as will be described.

Partial Airway Obstruction Algorithm

The Partial Airway Obstruction Detection Algorithm (step 400) isdiagramed in FIG. 6. It analyzes a breath, previously detected by theBreath Detection Algorithm (step 300), for the presence of a partialairway obstruction (partial obstruction of the upper airway).

When the patient 1 breathes, pressure gradients are generated betweenthe lungs and atmosphere. The physiology of the upper airway combinedwith these pressure gradients and Bernoulli's Effect can result inpartial collapse of the upper airway during inspiration. This partialcollapse is prevalent in people with obstructive sleep apnea.

In order to determine if a breath contains a partial airway obstruction,Fourier analysis is used to analyze the inspiratory flow for featuresspecific to partial airway obstruction. Once a signal has been mapped tothe frequency domain via a Fourier transform, there are many ways torepresent and analyze the frequency domain information. One couldanalyze the direct result of the Fourier transform, which would give theamplitude of the Fourier transform's sine component (informationrepresentative of the odd component of the original signal) and theamplitude of the Fourier transform's cosine component (informationrepresenting the even component of the original signal). Alternatively,from the Fourier transform, one could construct a phase v. frequencyplot and an energy v. frequency plot (energy spectrum). The phase andenergy information could be used to analyze the original waveform. Analternative to the energy v. frequency plot is to construct a magnitudev. frequency plot. In the preferred embodiment an energy spectrum isused to determine the presence of partial airway obstruction. Partialairway obstructions can be detected from analysis of the energy spectrumat low frequencies, as illustrated in FIGS. 1 and 2.

In particular, energy statements involving groupings of the frequencyharmonics of the Fourier transform of the flow of therapeutic gas to thepatient are generated from frequency-domain considerations. Thistechnique allows analysis of signals that might have a considerableamount of background noise. All processing and analysis is done in thefrequency domain based upon observed relationships between the patient'sresponses and the character of the energy spectrum in the frequencydomain.

Additionally, severe airway obstruction often results in a reduced peakflow-rate during inspiration, which results in a prolongation of timespent inspiring relative to expiring. This increase in inspiratory timeis incorporated in the Partial Airway Obstruction Detection Algorithm.

To obtain information solely from the inspiratory phase of therespiratory cycle, Fourier analysis is performed on a waveformconsisting of two inspiratory phases oppositely combined. The result isan odd function defined as

f(−x)=−f(x)   (1)

The standard Fourier series definition is

${f(x)} = {\frac{A_{0}}{2} + {\sum\limits_{n = 1}^{\infty}\; ( {{A_{n}\cos \frac{n\; \pi \; x}{T}} + {B_{n}\sin \frac{n\; \pi \; x}{T}}} )}}$

where n is the number of harmonics, A_(n) are the harmonic cosinecoefficients, B_(n) are the harmonic sine coefficients, and T is theperiod of cycle. Modifying Equation (2) according to Equation (1) gives

${f(x)} = {\sum\limits_{n = 1}^{\infty}{B_{n}\sin \frac{n\; \pi \; x}{T}}}$

as all A_(n), which represent the even part of the function, are zero.

To apply Fourier analysis to the inspiratory waveform, the algorithm ofthe preferred embodiment of the present invention first samples theincoming flow signal. Inspiration is then separated from expiration andmanipulated as in Equation (1) to give a vector of N data points, y=[y₁y₂ . . . y_(N)], that represent a single period of a cyclic function.The data is sampled evenly in time, hence t_(j−1)=τj where τ is thesampling interval between data points j=0, . . . −1. The discreteFourier transform of y is defined as

$Y_{k + 1} = {\sum\limits_{j = 0}^{N - 1}\; {y_{j + 1}^{{- 2}\pi \; {{ijk}/N}}}}$

where i is the square root of negative one and k=0, . . . , N−1. Eachpoint Y_(k-i) of the transform has an associated frequency,

f _(k+1) =k/τN   (5)

In the preferred embodiment, the fundamental frequency, k=1, is definedas f₂=1/τN and the first harmonic frequency, k=2, is defined as f₃=2/τN.

In order to determine whether a breath is a partial airway obstruction,the relative energy of specific frequencies and groups of frequencies isanalyzed. To do this the energy spectrum is calculated,

W _(k+1) =|Y _(k+1)|²   (6)

and normalized such that the total energy equals one.

In the preferred embodiment, the first 13 harmonics are considered foranalysis, as the relative power in the higher harmonics is minuscule.The analyzed harmonics are in the frequency range of zero to 25 Hz. Theenergy distribution of an inspiratory contour of a normal breathgenerally will have a majority of energy situated at W₂, which isassociated with the fundamental frequency, and a small amount of energyis distributed among the harmonics. The present invention uses thischaracteristic of the energy spectrum as developed through Fourieranalysis to posit that if the relative energy situated at a particularfrequency or group of frequencies is above an empirically-observedthreshold, the breath is deemed to be a partial airway obstruction.

Generally, for a normal breath the percentage of time spent inspiring is40 percent and expiring is 60 percent. The patient 1 with a partiallycollapsed airway cannot achieve maximum inspiratory flow. Accordingly,the patient 1 extends the time spent inspiring relative to expiring. Thetime spent inspiring increases to 50 percent or more of the total breathduring a partial airway obstruction.

Accordingly, the Partial Airway Obstruction Detection Algorithm firstcalculates an initial ratio, I_(insp), which is the portion of theentire breath spent on inspiration greater than the mean (step 402).Note that bias flow has been previously removed (steps 204, 206), so themean of the breath should be zero or very close to zero. Next, thealgorithm determines the inspiratory part of the breath and constructs awaveform consisting of two inspiratory phases oppositely combined (step404). Then, the algorithm calculates the discrete energy spectrum of theoppositely combined waveform as a function of frequency f (step 406):

W(f)=|FFT(waveform)|²

It is assumed that no significant energy is contained in the frequencies(or harmonics) above a predetermined level, preferably 13 times thefundamental frequency. Therefore, the energy spectrum is only retained,in the preferred embodiment, up to 13 times the fundamental frequency(step 408). Next, the algorithm normalizes the energy spectrum such thatthe total energy equals one (step 410):

normalized energy spectrum=W(f)/ΣW(F)

This calculation is done so that all breaths will be analyzed the same,even though each breath may differ from another breath in duration,tidal volume, and maximum flow.

Next, the algorithm groups energies corresponding to different harmonicfrequencies into information-bearing values (step 412). Theseinformation-bearing values are compared to threshold values that arecalculated in accordance with the percentage of the breath that is spendon inspiration (step 414). The information-bearing values and thethreshold values are determined empirically.

In the preferred embodiment, four information-bearing values are used:W_(first), W_(second), W_(freq), and W_(high) _(—) _(freq), as follows:

W_(first) = W₃ W_(second) = W₄$W_{freq} = {\sum\limits_{k = 2}^{14}\; W_{k + 1}}$$W_{high\_ freq} = {\sum\limits_{k = 6}^{14}\; W_{k + 1}}$

According, W_(first) corresponds to the energy in the first harmonic,W_(second) corresponds to the energy in the second harmonic, W_(freq)corresponds to the energy in the first 13 harmonics, and W_(high) _(—)_(freq) corresponds to the energy in the harmonics five through 13.Other information-bearing values can be obtained from the energiescorresponding to different harmonic frequencies using other mathematicaloperations.

In the preferred embodiment, two thresholds are used, T_(freq) andT_(high) _(—) _(freq). These values vary depending on the value ofI_(insp), the percentage of the breath spend inspiring (calculated atstep 402) and have been determined empirically to be:

Threshold I_(insp) Value T_(freq) I_(insp) ≦ 40 0.15 T_(freq) 40 <I_(insp) 50 −0.005 × I_(insp) + 0.35 T_(freq) I_(insp) ≧ 50 0.1 T_(high)_(—) _(freq) I_(insp) ≦ 40 0.03 T_(high) _(—) _(freq) 40 < I_(insp) 60−0.001 × I_(insp) + 0.07 T_(high) _(—) _(freq) I_(insp) ≧ 60 0.01

Using these empirically-determined values, the algorithm computes theinformation-bearing summations to the thresholds. If W_(second) isgreater than or equal to 0.1 (step 416), the breath is a partial airwayobstruction (step 418). If W_(first) is greater than or equal to 0.02,W_(second) is greater than or equal to 0.02, and W_(freq) is greaterthan or equal to 0.12 (step 420), the breath is a partial airwayobstruction (step 422). If the sum of W_(first) and W_(second) isgreater than or equal to 0.06 and W_(freq) is greater than or equal to0.12 (step 424), the breath is a partial airway obstruction (step 426).If the sum of W_(first) and W_(second) is greater than or equal to 0.07and W_(freq) is greater than or equal to 0.11 (step 428), the breath isa partial airway obstruction (step 430). If W_(freq) is greater than orequal to T_(freq) (step 432), the breath is a partial airway obstruction(step 434). If W_(high) _(—) _(freq) is greater than or equal toT_(high) _(—) _(freq) (step 436), the breath is a partial airwayobstruction (step 438). If none of these comparisons is true, the breathis normal (step 440).

Apnea Detection Algorithm

The Apnea Detection Algorithm (step 500) is diagramed in FIG. 7. Inorder to detect an apnea (cessation of flow), the controller 9 comparesthe incoming flow data (minus bias flow) with a threshold, μ₁,determined by the previous peak inspiratory flow. The Breath DetectionAlgorithm (step 300) had previously stored the maximum or peakinspiratory flow, not part of a hypopnea. The Apnea Detection Algorithmcalculates the threshold, μ₁, as 20 percent of the average peakinspiratory flow of the oldest five breaths of the last ten breaths(step 502). The algorithm then calculates T_(apnea) (step 504):

T _(apnea)=1.7×(breathing period averaged over last 50 breaths)

T_(apnea), however, must be between ten and fifteen seconds.

If the incoming flow is less than the threshold, μ₁, an apnea may beoccurring. If this condition is met for time greater than T_(apnea)(step 506), then an apnea is occurring (step 508), otherwise, no apneaoccurred (step 510). If an apnea is occurring, the algorithm checks tosee when the flow has increased to more than the threshold, μ₁ (step512), indicating that the apnea has finished.

Hypopnea Detection Algorithm

In order to detect a hypopnea (reduction of flow), the HypopneaDetection Algorithm (step 600), as diagramed in FIG. 8, compares thestored breath with a threshold, μ₂, determined by the previous peakinspiratory flow (step 602). Similar to the Apnea Detection Algorithm(step 500), the threshold, μ₂, is calculated from the peak inspiratoryflow for the oldest five breaths of the last ten that did not constitutepart of a hypopnea. The threshold (μ₂) is then taken as 60 percent ofthe average peak inspiratory flow of the oldest five breaths (step 602).

If incoming flow is less than the threshold (μ₂), for a period of timegreater than 12 seconds (step 604), then a possible hypopnea hasoccurred; otherwise, no hypopnea is occurring (step 606). For the eventto be classified as a hypopnea, there must be an increase in flow suchthat flow is greater than μ₂ within 30 seconds since the flow was lessthan μ₂ (step 608). If this increase in flow is detected, a hypopneaoccurred (step 610); otherwise, the event was not a hypopnea (step 612).

Pressure Adjusting Algorithm

If an apnea was detected during the Apnea Detection Algorithm (step500), the Pressure Adjusting Algorithm (step 700) is called. Also, if ahypopnea was detected during the Hypopnea Detection Algorithm (step600), and there were partial airway obstruction breaths in the hypopnea(step 228), or if there was no hypopnea but the current breath and twoprevious breaths were partial airway obstructions (steps 226, 232, 234),the Pressure Adjusting (step 700) algorithm is called. If there was nohypopnea, and either the current breath does not show a partial airwayobstruction or the previous two breaths did not show a partial airwayobstruction, but is has been 2.5 minutes since the last partial airwayobstruction (steps 226, 232, 234, 224), the Pressure Adjusting Algorithmis called. Also, if there was a hypopnea, but without any partial airwayobstruction breaths, and it has been longer than a predetermined periodsince the last partial airway obstruction event or apnea, preferably 2.5minutes (steps 226, 228, and 230), the Pressure Adjusting Algorithm(step 700) is called. The Pressure Adjusting Algorithm is diagramed inFIGS. 9 a through 9 d.

The Pressure Adjusting Algorithm (step 700) determines whether to adjustthe pressure and by how much, in order to control the therapeuticpressure delivered to the patient. As an initial rule of the preferredembodiment, this algorithm will only increase pressure to a maximum of10 cm H₂O on an event classified as an apnea (step 702).

The algorithm first checks to determine if there have been any pressuredecreases since the beginning of the period of sleep (step 704). Ifthere have not been any such decreases, the algorithm determines if anobstructive event of any sort has been detected and whether the pressureis under a predetermined maximum, preferably ten cm H₂O (step 706). Ifthese conditions are met, the algorithm determines whether theobstructive event was a partial airway obstruction, an apnea, or ahypopnea with a partial airway obstruction (step 708). In the event of ahypopnea with a partial airway obstruction, the controller 9 increasespressure by one cm H₂O (step 710) and waits ten seconds before allowinganother pressure change (step 712). If the event was an apnea, thecontroller 9 increases pressure by two cm H₂O (step 714) and waits 60seconds before allowing another pressure change (step 716). If the eventwas a partial airway obstruction, the controller 9 increases pressure byone cm H₂O (step 718) and waits ten seconds before allowing anotherpressure change (step 720).

If there have been previous pressure decreases since the beginning ofthe period of sleep (step 704), or if the conditions of a detectedobstructive event and the pressure being less than ten cm H₂O have notbeen met (step 706), the algorithm determines if there have been sixconsecutive pressure decreases. If so, total consecutivepressure-decrease counter 130 is reset to zero (step 722).

The algorithm next determines if there has been normal breathing for apredetermined period of time, preferably 2.5 minutes (step 724). If so,the controller 9 decreases the pressure by 0.5 cm H₂O (step 726) (andincrements pressure-decrease counter 130 by one).

If there has not been normal breathing for the predetermined period oftime (step 724), then either a partial airway obstruction, an apnea, ora hypopnea with partial airway obstruction has occurred (step 728). Thenext step depends on the previous pressure changes. If the previousconsecutive pressure changes have been increases totaling greater thanor equal to a total of one cm H₂O, and the current pressure is less thanten cm H₂O (step 730), the algorithm proceeds to step 708 as describedabove. If not, the controller 9 proceeds to increase the pressure by anamount depending on the nature of the obstructive event and the amountof previous pressure decreases, as diagramed in FIGS. 9 b, 9 c, and 9 d.

If the total previous pressure decreases were more than one cm H₂O (step732), the algorithm determines if the obstructive event was a partialairway obstruction, an apnea, or a hypopnea with partial airwayobstruction (step 734). In the event of a hypopnea with a partial airwayobstruction, the controller 9 increases pressure by one cm H₂O (step736) and waits ten seconds before allowing another pressure change (step738). If the event was an apnea, the controller 9 increases pressure bytwo cm H₂O (step 740) and waits 60 seconds before allowing anotherpressure change (step 742). If the event was a partial airwayobstruction, the controller 9 increases pressure by 0.5 cm H₂O (step744) and waits ten seconds before allowing another pressure change (step746).

If the previous pressure decreases were more than one cm H₂O but notmore than 1.5 cm H₂O (step 748), the algorithm determines if theobstructive event was a partial airway obstruction, an apnea, or ahypopnea with partial airway obstruction (step 750). In the event of ahypopnea with partial airway obstruction, the controller 9 increasespressure by one cm H₂O (step 752) and waits ten seconds before allowinganother pressure change (step 754). If the event was an apnea, thecontroller 9 increases pressure by two cm H₂O (step 756) and waits 60seconds before allowing another pressure change (step 758). If the eventwas a partial airway obstruction, the controller 9 increases pressure by0.5 cm H₂O (step 760) and waits ten seconds before allowing anotherpressure change (step 762).

If the previous pressure decreases were more than 1.5 cm H₂O but notmore than two cm H₂O (step 764) (FIG. 9 c), the algorithm determines ifthe obstructive event was a partial airway obstruction, an apnea, or ahypopnea with partial airway obstruction (step 766). In the event of ahypopnea with partial airway obstruction, the controller 9 increasespressure by 1.5 cm H₂O (step 768) and waits ten seconds before allowinganother pressure change (step 770). If the event was an apnea, thecontroller 9 increases pressure by two cm H₂O (step 772) and waits 60seconds before allowing another pressure change (step 774). If the eventwas a partial airway obstruction, the controller 9 increases pressure byone cm H₂O (step 776). and waits ten seconds before allowing anotherpressure change (step 778).

If the previous pressure decreases were more than two cm H₂O but lessthan or equal to 3.5 cm H₂O (step 780), the algorithm determines if theobstructive event was a partial airway obstruction, an apnea, or ahypopnea with partial airway obstruction (step 782). In the event of ahypopnea with partial airway obstruction, the controller 9 increasespressure by 1.5 cm H₂O (step 784) and waits ten seconds before allowinganother pressure change (step 754). If the event was an apnea, thecontroller 9 increases pressure by two cm H₂O (step 788) and waits 60seconds before allowing another pressure change (step 790). If the eventwas a partial airway obstruction, the controller 9 increases pressure by1.5 cm H₂O (step 792) and waits ten seconds before allowing anotherpressure change (step 794).

If the previous pressure decreases were more than 3.5 cm H₂O (step 796),the algorithm determines if the obstructive event was a partial airwayobstruction, an apnea, or a hypopnea with partial airway obstruction(step 798). In the event of a hypopnea with partial airway obstruction,the controller 9 increases pressure by one-half the total pressuredecrease (step 800) and waits ten seconds before allowing anotherpressure change (step 802). If the event was an apnea, the controller 9increases pressure by one-half the total pressure decrease (step 804)and waits 60 seconds before allowing another pressure change (step 806).If the event was a partial airway obstruction, the controller 9increases pressure by one-half the total pressure decrease (step 808)and waits ten seconds before allowing another pressure change (step810).

While preferred embodiments of the present invention are shown anddescribed, it is envisioned that those skilled in the art may devisevarious modifications of the present invention without departing fromthe spirit and scope of the appended claims.

1. A method of controlling positive airway pressure therapy, comprisingthe steps of: providing a flow of gas to a patient's airway at apressure; obtaining a signal relating to said flow; obtaininginformation from a frequency range of 0 to 25 Hz in a frequency domainof said signal; said information comprising a discrete energy spectrumof inspiration of the patient; and adjusting said pressure based on saidinformation.
 2. The method of claim 1, wherein said informationcomprises at least one information-bearing value generated from saidfrequency domain information.
 3. The method of claim 2, wherein saidadjusting step further comprises comparing said at least oneinformation-bearing value to a threshold.
 4. The method of claim 2,wherein said adjusting step further comprises comparing said at leastone information-bearing value to one of a plurality of thresholds. 5.The method of claim 2, further comprising the steps of calculating aperiod of breath of a patient and calculating an inspiratory portion ofsaid period, and wherein said adjusting step comprises comparing said atleast one information-bearing value to one of a plurality of thresholds,said one of a plurality of thresholds being selected according to aratio of said inspiratory portion to said period.
 6. The method of claim2, wherein said information-bearing value comprises at least an energyin a first harmonic of said discrete energy spectrum and an energy in asecond harmonic of said discrete energy spectrum.
 7. The method of claim6, wherein said adjusting step further comprises comparing said at leastone information-bearing value to a threshold.
 8. The method of claim 6,wherein said adjusting step further comprises comparing said at leastone information-bearing value to one of a plurality of thresholds. 9.The method of claim 6, further comprising the steps of calculating aperiod of a breath of a patient and calculating an inspiratory portionof said period, and wherein said adjusting step comprises comparing saidat least one information-bearing value to one of a plurality ofthresholds, said one of a plurality of thresholds being selectedaccording to a ratio of said inspiratory portion to said period.
 10. Themethod of claim 2, wherein said at least one information-bearing valuecomprises an energy in a first harmonic of said discrete energyspectrum, an energy in a second harmonic of said discrete energyspectrum, a sum of energies of said first harmonic through a thirteenthharmonic of said discrete energy spectrum, and a sum of energies of afifth harmonic through said thirteenth harmonic of said discrete energyspectrum.
 11. The method of claim 10 wherein said adjusting step furthercomprises comparing said at least one information-bearing value to athreshold.
 12. The method of claim 10, wherein said adjusting stepfurther comprises comparing said at least one information-bearing valueto one of a plurality of thresholds.
 13. The method of claim 10, furthercomprising the steps of calculating a period of a breath of a patientand calculating an inspiratory portion of said period, and wherein saidadjusting step comprises comparing said at least one information-bearingvalue to one of a plurality of thresholds, said one of a plurality ofthresholds being selected according to a ratio of said inspiratoryportion to said period.
 14. The method of claim 2, wherein said at leastone information-bearing value comprises a plurality ofinformation-bearing values.
 15. The method of claim 14, wherein saidadjusting step further comprises comparing each of said plurality ofinformation-bearing values to a threshold.
 16. The method of claim 14,wherein said adjusting step further comprises comparing each of saidplurality of information-bearing values to one of a plurality ofthresholds.
 17. The method of claim 14, further comprising the steps ofcalculating a period of a breath of a patient and calculating aninspiratory portion of said period, and wherein said adjusting stepcomprises comparing each of said plurality of information-bearing valuesto one of a plurality of thresholds, said one of a plurality ofthresholds being selected according to a ratio of said inspiratoryportion to said period.
 18. The method of claim 14, wherein saidplurality of information-bearing values comprises at least an energy ina first harmonic of said discrete energy spectrum and an energy in asecond harmonic of said discrete energy spectrum.
 19. The method ofclaim 18, wherein said adjusting step further comprises comparing eachof said plurality of information-bearing values to a threshold.
 20. Themethod of claim 18, wherein said adjusting step further comprisescomparing each of said plurality of information-bearing values to one ofa plurality of thresholds.
 21. The method of claim 18, furthercomprising the steps of calculating a period of a breath of a patientand calculating an inspiratory portion of said period, and wherein saidadjusting step comprises comparing each of said plurality ofinformation-bearing values to one of a plurality of thresholds, said oneof a plurality of thresholds being selected according to a ratio of saidinspiratory portion to said period.
 22. The method of claim 14, whereinsaid plurality of information-bearing values comprises an energy in afirst harmonic of said discrete energy spectrum, an energy in a secondharmonic of said discrete energy spectrum, a sum of energies of saidfirst harmonic through a thirteenth harmonic of said discrete energyspectrum, and a sum of energies of a fifth harmonic through saidthirteenth harmonic of said discrete energy spectrum.
 23. The method ofclaim 22 wherein said adjusting step further comprises comparing each ofsaid plurality of information-bearing values to a threshold.
 24. Themethod of claim 22, wherein said adjusting step further comprisescomparing each of said plurality of information-bearing values to one ofa plurality of thresholds.
 25. The method of claim 22, furthercomprising the steps of calculating a period of a breath of a patientand calculating an inspiratory portion of said period, and wherein saidadjusting step comprises comparing each of said plurality ofinformation-bearing values to one of a plurality of thresholds, said oneof a plurality of thresholds being selected according to a ratio of saidinspiratory portion to said period.
 26. An apparatus for controllingpositive airway pressure therapy, comprising: a blower for providing aflow of gas to a patient at a pressure; a sensor to measure acharacteristic of said flow and to provide a signal relating to saidcharacteristic; a controller to obtain information from a frequencyrange of 0 to 25 Hz in a frequency domain of said signal; saidinformation comprising a discrete energy spectrum of inspiration of thepatient; and a pressure regulator controlled by said controller foradjusting said pressure based on said information.
 27. The apparatus ofclaim 26, wherein said information comprises at least oneinformation-bearing value generated from said frequency domaininformation.
 28. The apparatus of claim 27, wherein said controllerfurther compares at least one information-bearing value to a threshold.29. The apparatus of claim 27, wherein said controller further comparesat least one information-bearing value to one of a plurality ofthresholds.
 30. The apparatus of claim 27, wherein said controllerfurther calculates a period of breath of a patient and an inspiratoryportion of said period, and further compares said at least oneinformation-bearing value to one of a plurality of thresholds, said oneof a plurality of thresholds being selected according to a ratio of saidinspiratory portion to said period.
 31. The apparatus of claim 26,wherein said at least one information-bearing value comprises at leastan energy in a first harmonic of said discrete energy spectrum and anenergy in a second harmonic of said discrete energy spectrum.
 32. Theapparatus of claim 31, wherein said controller further compares said atleast one information-bearing value to a threshold.
 33. The apparatus ofclaim 31, wherein said controller further compares said at least oneinformation-bearing value to one of a plurality of thresholds.
 34. Theapparatus of claim 31, wherein said controller further calculates aperiod of a breath of a patient and an inspiratory portion of saidperiod, and further compares said at least one information-bearing valueto one of a plurality of thresholds, said one of a plurality ofthresholds being selected according to a ratio of said inspiratoryportion to said period.
 35. The apparatus of claim 26, wherein said atleast one information-bearing value comprises an energy in a firstharmonic of said discrete energy spectrum, an energy in a secondharmonic of said discrete energy spectrum, a sum of energies of saidfirst harmonic through a thirteenth harmonic of said discrete energyspectrum, and a sum of energies of a fifth harmonic through saidthirteenth harmonic of said discrete energy spectrum.
 36. The apparatusof claim 35, wherein said controller further compares said at least oneinformation-bearing value to a threshold.
 37. The apparatus of claim 35,wherein said controller further compares said at least oneinformation-bearing value to one of a plurality of thresholds.
 38. Theapparatus of claim 35, wherein said controller further calculates aperiod of a breath of a patient and an inspiratory portion of saidperiod, and further compares said at least one information-bearing valueto one of a plurality of thresholds, said one of a plurality ofthresholds being selected according to a ratio of said inspiratoryportion to said period.
 39. The apparatus of claim 26, wherein said atleast one information-bearing value comprises a plurality ofinformation-bearing values.
 40. The apparatus of claim 39, wherein saidcontroller further compares each of said plurality ofinformation-bearing values to a threshold.
 41. The apparatus of claim39, wherein said controller further compares said plurality ofinformation-bearing values to one of a plurality of thresholds.
 42. Theapparatus of claim 39, wherein said controller further calculates aperiod of a breath of a patient and an inspiratory portion of saidperiod, and further compares said plurality of information-bearingvalues to one of a plurality of thresholds, said one of a plurality ofthresholds being selected according to a ratio of said inspiratoryportion to said period.
 43. The apparatus of claim 39, wherein saidplurality of information-bearing values comprises at least an energy ina first harmonic of said discrete energy spectrum and an energy in asecond harmonic of said discrete energy spectrum.
 44. The apparatus ofclaim 43, wherein said controller further compares each of saidplurality of information-bearing values to a threshold.
 45. Theapparatus of claim 43, wherein said controller further compares each ofsaid plurality of information-bearing values to one of a plurality ofthresholds.
 46. The apparatus of claim 43, wherein said controllerfurther calculates a period of a breath of a patient and an inspiratoryportion of said period, and further compares each of said plurality ofinformation-bearing values to one of a plurality of thresholds, said oneof a plurality of thresholds being selected according to a trio of saidinspiratory portion to said period.
 47. The apparatus of claim 39,wherein said plurality of information-bearing values comprises an energyin a first harmonic of said discrete energy spectrum, an energy in asecond harmonic of said discrete energy spectrum, a sum of energies ofsaid first harmonic through a thirteenth harmonic of said discreteenergy spectrum, and a sum of energies of a fifth harmonic through saidthirteenth harmonic of said discrete energy spectrum.
 48. The apparatusof claim 47, wherein said controller further compares each of saidplurality of information-bearing values to a threshold.
 49. Theapparatus of claim 47, wherein said controller further compares each ofsaid plurality of information-bearing values to one of a plurality ofthresholds.
 50. The apparatus of claim 47, wherein said controllerfurther calculates a period of a breath of a patient and an inspiratoryportion of said period, and further compares each of said plurality ofinformation-bearing values to one of a plurality of thresholds, said oneof a plurality of thresholds being selected according to a ratio of saidinspiratory portion to said period.
 51. A method of controlling positiveairway pressure therapy, comprising the steps of: providing a flow ofgas to a patient's airway at a pressure; obtaining at least oneinformation-bearing value bearing value from a frequency range of 0 to25 Hz in a frequency domain of said flow; adjusting said pressure basedon said information; and calculating a period of breath of a patient andcalculating an inspiratory portion of said period, and wherein saidadjusting step comprises comparing said at least one information-bearingvalue to one of a plurality of thresholds, said one of a plurality ofthresholds being selected according to a ratio of said inspiratoryportion to said period.
 52. An apparatus for controlling positive airwaypressure therapy, comprising: a blower for providing a flow of gas to apatient at a pressure; a sensor to measure a characteristic of saidflow; a controller to obtain information from a frequency range of 0 to25 Hz in a frequency domain of said characteristic; and a pressureregulator controlled by said controller for adjusting said pressurebased on said information; said information comprises at least oneinformation-bearing value generated from said frequency domaininformation; and said controller further calculates a period of a breathof a patient and an inspiratory portion of said period, and comparingsaid at least one information-bearing value to one of a plurality ofthresholds, said one of a plurality of thresholds being selectedaccording to a ratio of said inspiratory portion to said period.
 53. Amethod of controlling positive airway pressure therapy, comprising thesteps of: providing a flow of gas to a patient's airway at a supplypressure that does not include forced oscillation at a frequency greaterthan the breathing rate of the patient; obtaining information from afrequency range of 0 to 25 Hz in a frequency domain of said flow; andadjusting said pressure based on said information.
 54. The method ofclaim 53, wherein said information comprises at least oneinformation-bearing value generated from said frequency domaininformation.
 55. The method of claim 54, further comprising the steps ofcalculating a period of a breath of a patient and calculating aninspiratory portion of said period, and wherein said adjusting stepcomprises comparing said at least one information-bearing value to oneof a plurality of thresholds, said one of a plurality of thresholdsbeing selected according to a ratio of said inspiratory portion to saidperiod.
 56. An apparatus for controlling positive airway pressuretherapy, comprising: a blower for providing a flow of gas to a patientat a pressure that does not include forced oscillation at a frequencygreater than the breathing rate of the patient; a sensor to measure acharacteristic of said flow; a controller to obtain information from afrequency range of 0 to 25 Hz in a frequency domain of saidcharacteristic; and a pressure regulator controlled by said controllerfor adjusting said pressure based on said information.
 57. The apparatusof claim 56, wherein said information comprises at least oneinformation-bearing value generated from said frequency domaininformation.
 58. The apparatus of claim 57, wherein said controllerfurther calculates a period of a breath of a patient and an inspiratoryportion of said period, and further compares said at least oneinformation-bearing value to one of a plurality of thresholds, said oneof a plurality of thresholds being selected according to a ratio of saidinspiratory portion to said period.